Effect of human milk-based fortification in extremely preterm infants fed exclusively with breast milk: a randomised controlled trial.

Background: Mortality and severe morbidity remain high in extremely preterm infants. Human milk-based nutrient fortifiers may prevent serious complications and death. We aimed to investigate whether supplementation with human milk-based fortifier (HMBF), as compared to bovine milk-based fortifier (BMBF), reduced the incidence of the composite outcome of necrotising enterocolitis (NEC), sepsis, and mortality in extremely preterm infants exclusively fed human milk. Methods: In this multicentre, randomised controlled trial at 24 neonatal units in Sweden, extremely preterm infants born between gestational week 22 + 0 and 27 + 6 fed exclusively human breast milk (mother's own and/or donor milk), were randomly assigned (1:1) to receive targeted fortification with either HMBF or BMBF. Randomisation was conducted before the enteral feeds reached 100 mL/kg/day, and was stratified by enrolment site, gestational age, singleton/twin, and sex. The allocation was concealed before inclusion, but after randomisation the study was not blinded for the clinical staff. For the NEC diagnosis, the study group was masked to an independent radiologist, and the final assessment of NEC and culture-proven sepsis was done by a blinded consensus panel review. The primary outcome was the composite of NEC stage II-III, culture-proven sepsis, and mortality from inclusion to discharge, no longer than postmenstrual week 44 + 0, in the intention-to-treat population (ClinicalTrials.gov, NCT03797157). Findings: Between February 21st, 2019, and May 21st, 2021, 229 neonates were randomly assigned (115 HMBF, 114 BMBF). After exclusion of one infant due to parents' withdrawal of consent, 228 infants were included in the intention-to-treat analysis. Of the 115 infants assigned to HMBF, 41 (35.7%) fulfilled the criteria of either NEC, sepsis, or death, compared with 39 (34.5%) of 113 infants assigned to BMBF (OR 1.05, 95% CI 0.61-1.81, p = 0.86). Adverse events did not differ significantly between groups. Interpretation: Supplementation with HMBF, as compared with BMBF, did not reduce the incidence of the composite outcome of NEC, sepsis, or death. Our results do not support routine supplementation with HMBF as a nutritional strategy to prevent NEC, sepsis, or death in extremely preterm infants exclusively fed human milk. Funding: ALF grant, Prolacta Bioscience, Swedish Research Council, and Research Council for Southeast Sweden.

Human visceral and subcutaneous adipose stem and progenitor cells retain depot-specific adipogenic properties during obesity.

Abdominal obesity associates with cardiometabolic disease and an accumulation of lipids in the visceral adipose depot, whereas lipid accumulation in the subcutaneous depot is more benign. We aimed to further investigate whether the adipogenic properties where cell-intrinsic, or dependent on a depot-specific or obesity-produced microenvironment. We obtained visceral and subcutaneous biopsies from non-obese women (n = 14) or women living with morbid obesity (n = 14) and isolated adipose stem and progenitor cells (ASPCs) from the stromal vascular fraction of non-obese (n = 13) and obese (n = 13). Following in vitro differentiation into mature adipocytes, we observed a contrasting pattern with a lower gene expression of adipogenic markers and a higher gene expression of immunogenic markers in the visceral compared to the subcutaneous adipocytes. We identified the immunogenic factor BST2 as a marker for visceral ASPCs. The effect of obesity and insulin resistance on adipogenic and immunogenic markers in the in vitro differentiated cells was minor. In contrast, differentiation with exogenous Tumor necrosis factor resulted in increased immunogenic signatures, including increased expression of BST2, and decreased adipogenic signatures in cells from both depots. Our data, from 26 women, underscore the intrinsic differences between human visceral and subcutaneous adipose stem and progenitor cells, suggest that dysregulation of adipocytes in obesity mainly occurs at a post-progenitor stage, and highlight an inflammatory microenvironment as a major constraint of human adipogenesis.

Gastric Aspiration Improves Postprandial Glucose Tolerance Without Causing a Compensatory Increase in Appetite and Food Intake.

INTRODUCTION: AspireAssist® allows aspiration of ~30% of an ingested meal through a percutaneous gastrostomy tube, reducing caloric uptake. We evaluated the acute effects of gastric aspiration on postprandial glucose tolerance, responses of gluco-regulatory and appetite-regulating hormones, appetite sensations, and food intake. METHODS: Seven AspireAssist®-treated individuals underwent two separate experimental days each involving a mixed meal test (MMT) with double-blinded aspiration and sham aspiration, respectively. Seven age and body mass index (BMI)-matched controls underwent one MMT. MMTs were followed by an ad libitum meal. RESULTS: Postprandial glucose tolerance was improved during aspiration vs. sham visits (median [interquartile range] baseline-subtracted area under the curve (bsAUC) 170 [88.4;356] vs. 388 [239;456] mmol/L × min, p = 0.025). Reduced responses (bsAUCs) of C-peptide (113 [28.4;224] vs. 302 [215;433] nmol/L × min, p = 0.014), cholecystokinin (223 [59.4;402] vs. 467 [416;546] pmol/L × min, p = 0.005), glucose-dependent insulinotropic polypeptide (4.63 [1.49;9.04] vs. 15.4 [9.59;18.9] nmol/L × min, p = 0.025), and glucagon-like peptide 1 (532.8 [274.5;1,278] vs. 1,296 [746.2;1,618] pmol/L × min, p = 0.032) were observed during aspiration vs. sham visits. Responses of glucagon, gastrin, ghrelin and peptide YY, appetite sensations, and ad libitum food intake were unaffected by aspiration. Responses of plasma glucose, gut hormones, appetite sensations, and food intake were similar during sham and control visits. CONCLUSION: Gastric aspiration improved postprandial glucose tolerance without causing compensatory increases in appetite or food intake, pointing to acute beneficial metabolic effects of aspiration therapy together with previously reported body weight-lowering effects.

Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS): Results of a Multinational, Randomized, Controlled, and Double-blind Trial.

OBJECTIVE: The aim of this study was to investigate the approach (open or laparoscopic) and mesh type (synthetic or biological) in ventral hernias in a clean setting.Summary of Background Data: The level of evidence on the optimal surgical approach and type of mesh in ventral hernia repair is still low. METHODS: Patients with a ventral abdominal hernia (diameter 4-10 cm) were included in this double-blind randomized controlled trial across 17 hospitals in 10 European countries. According to a 2 × 2-factorial design, patients were allocated to 4 arms (open retromuscular or laparoscopic intraperitoneal, with synthetic or Surgisis Gold biological mesh). Patients and outcome assessors were blinded to mesh type used. Major postoperative complication rate (hernia recurrence, mesh infection, or reoperation) within 3 years after surgery, was the primary endpoint in the intention-to-treat population. RESULTS: Between September 1st, 2005, and August 7th, 2009, 253 patients were randomized and 13 excluded. Six of 61 patients (9.8%) in the open synthetic mesh arm, 15 of 66 patients (22.7%) in the open biological mesh arm, 7 of 64 patients (10.9%) in the laparoscopic synthetic mesh arm and 17 of 62 patients (27.4%) in the laparoscopic biological mesh arm had a major complication. The use of biological mesh resulted in significantly more complications (P = 0.013), also after adjusting for hernia type, body mass index, and study site. The trial was prematurely stopped due to an unacceptable high recurrence rate in the biological mesh arms. CONCLUSIONS: The use of Surgisis Gold biological mesh is not recommended for noncomplex ventral hernia repair. TRIAL REGISTRATION: This trial was registered at controlled-trials.com (ISRCTN34532248).

Contagiousness in treated HIV-1 infection.

BACKGROUND: Effective antiretroviral treatment of HIV-1, defined as continuously undetectable virus in blood, has substantial effects on the infectiousness and spread of HIV. AIM: This paper outlines the assessment of the Swedish Reference Group for Antiviral Therapy (RAV) and Public Health Agency of Sweden regarding contagiousness of HIV-infected persons on antiretroviral therapy (ART). Results and Conclusion: The expert group concludes that there is no risk of transmission of HIV during vaginal or anal intercourse if the HIV-infected person fulfils the criteria for effective ART. Summary: The effective antiretroviral therapy (ART) for HIV-1 infection has dramatically reduced the morbidity and mortality among people who live with HIV. ART also has a noticeable effect on the infectiousness and on the spread of the disease in society. Knowledge about this has grown gradually. For ART to be regarded effective, the level of the HIV RNA in the plasma should be repeatedly and continuously undetectable and the patient should be assessed as continually having high adherence to treatment. Based on available knowledge the Swedish Reference Group for Antiviral Therapy (RAV) and the Public Health Agency of Sweden make the following assessment: There is no risk of HIV transmission during vaginal or anal intercourse if the HIV positive person fulfils the criteria for effective treatment. This includes intercourse where a condom is not used. However, there are a number of other reasons for recommending the use of condoms, primarily to protect against the transmission of other STIs (sexually transmitted infections) and hepatitis, as well as unwanted pregnancy. The occurrence of other STIs does not affect the risk of HIV transmission in persons on effective ART. It is plausible that the risk for transmission of HIV infection between people who inject drugs and share injection equipment is reduced if the individual with HIV is on effective ART, but there are no studies that directly show this. The risk of transmission from mother to child during pregnancy, labour and delivery is very low if the mother's treatment is initiated well before delivery and if the treatment aim of undetectable virus levels is attained. This is dependent on healthcare services being aware of the mother's HIV infection at an early stage. In most contacts with health and medical care, including dental care, the risk of transmission is not significant if the patient is on effective treatment, but the risk may remain, although considerably reduced, in more advanced interventions such as surgery. When an incident with risk of transmission occurs, the patient must always inform those potentially exposed about his or her HIV infection.

Antiretroviral treatment for HIV infection: Swedish recommendations 2019.

The Swedish Reference Group for Antiviral Therapy (RAV) published recommendations for the treatment of HIV infection in this journal most recently in 2017. An expert group under the guidance of RAV here provides updated recommendations. The most important updates in the present guidelines are the following: (a) The risk of HIV transmission through condomless sex from individuals with fully suppressed HIV viral load is effectively zero. (b) Pre-exposure prophylaxis (PrEP) is recommended for groups with a high risk of HIV infection. (c) Since the last update, two new substances have been registered: bictegravir and doravirine. (d) Dual treatment may be an alternative in selected patients, using lamivudine + dolutegravir or lamivudine + boosted darunavir/atazanavir. As with previous publications, recommendations are evidence-graded in accordance with the Oxford Centre for Evidence Based Medicine. This document does not cover treatment of opportunistic infections and tumours.

Patient profiling for success after weight loss surgery (GO Bypass study): An interdisciplinary study protocol.

Despite substantial research efforts, the mechanisms proposed to explain weight loss after gastric bypass (RYGB) and sleeve gastrectomy (SL) do not explain the large individual variation seen after these treatments. A complex set of factors are involved in the onset and development of obesity and these may also be relevant for the understanding of why success with treatments vary considerably between individuals. This calls for explanatory models that take into account not only biological determinants but also behavioral, affective and contextual factors. In this prospective study, we recruited 47 women and 8 men, aged 25-56 years old, with a BMI of 45.8 ±â€¯7.1 kg/m2 from the waiting list for RYGB and SL at Køge hospital, Denmark. Pre-surgery and 1.5, 6 and 18 months after surgery we assessed various endpoints spanning multiple domains. Endpoints were selected on basis of previous studies and include: physiological measures: anthropometrics, vital signs, biochemical measures and appetite hormones, genetics, gut microbiota, appetite sensation, food and taste preferences, neural sensitivity, sensory perception and movement behaviors; psychological measures: general psychiatric symptom-load, depression, eating disorders, ADHD, personality disorder, impulsivity, emotion regulation, attachment pattern, general self-efficacy, alexithymia, internalization of weight bias, addiction, quality of life and trauma; and sociological and anthropological measures: sociodemographic measures, eating behavior, weight control practices and psycho-social factors.Joining these many endpoints and methodologies from different scientific disciplines and creating a multi-dimensional predictive model has not previously been attempted. Data on the primary endpoint are expected to be published in 2018. TRIAL REGISTRATION: Clinicaltrials. gov ID NCT02070081.

[Gastric aspiration therapy is a possible alternative to treatment of obesity].

Aspiration therapy with AspireAssist is a novel endoscopic obesity treatment. Patients aspirate approximately 30% of an ingested meal through a draining system connected to a percutanous endoscopic gastrostomy tube. AspireAssist was recently approved by the US Food and Drug Administration, and it induces weight loss comparable to the weight loss observed after bariatric surgery, but with a lower risk of complications. Few clinical studies about the efficacy and safety of AspireAssist have been carried out and published. Thus, further intervention studies evaluating acute as well as long-term effects are warranted.

Genetic variants in CYP2B6 and CYP2A6 explain interindividual variation in efavirenz plasma concentrations of HIV-infected children with diverse ethnic origin.

BACKGROUND: Approximately 2.6 million children live with HIV globally, and efavirenz (EFV) is one of the most widely used antiretroviral agents for HIV treatment in children and adults. There are concerns about the appropriateness of current EFV dosing and it has been discussed whether EFV dosing should be adapted according to genotype in children as suggested for adults. AIM: To investigate if pediatric EFV dosing should be guided by genetic variation in drug metabolizing enzymes rather than by body weight. METHOD: EFV plasma concentrations measured for clinical purposes from all children less than 18 years old at Karolinska University Hospital, Stockholm, Sweden, treated with EFV were collected retrospectively. They were genotyped for eleven polymorphisms in genes coding for drug-metabolizing enzymes and P-glycoprotein, of potential importance for EFV disposition. Data on country of origin, sex, age, weight, HIV RNA, viral resistance patterns, CD4 cells, adherence to treatment, subjective health status and adverse events were collected from their medical records. RESULTS: Thirty-six patients and 182 (mean 5 samples/patient) EFV plasma concentration measurements from children of African, Asian and Latin American origin were included. EFV plasma concentration varied 21-fold between measurements (n = 182) (0.85-19.3 mg/L) and 9-fold measured as mean EFV plasma concentration across the subjects (1.55-13.4 mg/L). A multivariate mixed-effects restricted maximum likelihood regression model, including multiple gene polymorphisms, identified CYP2B6*6 T/T (p < 0.0005), CYP2B6*11 G/G (p < 0.0005), CYP2A6*9 A/C (p = 0.001) genotypes, age at treatment initiation (p = 0.002) and time from treatment initiation (p < 0.0005) as independent factors significantly related to loge concentration/(dose/weight). The contribution of the model to the intra- and interindividual variation were 6 and 75%, respectively (Bryk/Raudenbush R-squared level). CONCLUSION: Genetic polymorphisms in CYP2B6 and CYP2A6 explained a significant proportion of variability in EFV plasma concentration in HIV-infected children in a multi-ethnic outpatient clinic. Knowledge about individual variants in key drug metabolizing enzyme genes could improve clinical safety and genotype directed dosing could achieve more predictable EFV plasma concentrations in HIV-infected children.

Treatment of Common Bile Duct Stones in Gastric Bypass Patients with Laparoscopic Transgastric Endoscopic Retrograde Cholangiopancreatography.

BACKGROUND: Laparoscopic Roux-en-Y gastric bypass excludes the biliary tree from traditional evaluation and treatment with endoscopic retrograde cholangiopancreatography (ERCP). Due to the initial rapid weight loss, gastric bypass patients have an increased risk of developing gallstones in the gallbladder as well as in the common bile duct. Various techniques to access the biliary tree have been described. The techniques are characterised by complexity and varying results. The aim of the present study was to assess both feasibility and outcome of laparoscopic-assisted transgastric ERCP in patients with gastric bypass. METHODS: We retrospectively reviewed all laparoscopic transgastric ERCPs performed at Zealand University Hospital during the period January 2010 to January 2016. The main outcome was cannulation of the common bile duct. Secondary outcomes were length of hospital stay and surgical complications. RESULTS: Thirty-one laparoscopic assisted transgastric ERCP procedures were performed in 29 patients. Indication was choledocholithiasis. All planned procedures were conducted with a 100% success in cannulation of the common bile duct. Median hospital stay was 2 days (range 1-22). Perforation of the wall of the gastric remnant occurred in two patients. The overall postoperative complication rate was 36%. Surgical complications were bleeding, haematoma and intra-abdominal abscesses. CONCLUSION: Laparoscopic assisted transgastric ERCP is feasible, but there are several complications related to the procedure. Thus, until better alternative treatments are developed, it is recommended that the procedure should be performed at centres with both high endoscopic and bariatric expertise.

Antiretroviral treatment for HIV infection: Swedish recommendations 2016.

The Swedish Medical Products Agency and the Swedish Reference Group for Antiviral Therapy (RAV) have jointly published recommendations for the treatment of HIV infection on seven previous occasions (2002, 2003, 2005, 2007, 2009, 2011 and 2014). In February 2016, an expert group under the guidance of RAV once more revised the guidelines. The most important updates in the present guidelines are as follows: Tenofovir alafenamide (TAF) has recently been registered. TAF has several advantages over tenofovir disoproxilfumarate (TDF) and is recommended instead of TDF in most cases. First-line treatment for previously untreated individuals includes dolutegravir, boosted darunavir or efavirenz with either abacavir/lamivudine or tenofovir (TDF/TAF)/emtricitabine. Pre-exposure prophylaxis (PrEP) is recommended for high-risk individuals. As in the case of the previous publication, recommendations are evidence-graded in accordance with the Oxford Centre for Evidence Based Medicine ( http://www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/ ) ( Table 1 ). This document does not cover treatment of opportunistic infections and tumours. [Table: see text].

Transition of HIV-infected youths from paediatric to adult care, a Swedish single-centre experience.

BACKGROUND: Transition of HIV-infected adolescents from paediatric care to adult care is vulnerable and entails a risk of treatment failure. Therefore, a Transitional Outpatient Clinic for HIV-infected adolescents and young adults was started in 2008. The aims were to describe the transition process and treatment results in a Swedish cohort of adolescents with HIV. MATERIALS AND METHODS: A cross-sectional study of the adolescent and young adults with HIV at the clinic was performed in October 2013 and a 2-year follow-up at the end of 2015. RESULTS: The 34 patients in care in October 2013 were a median of 19 years, 50% were female. Thirty-one out of 34 (91%) were perinatally infected. In 2013, 88% were on antiretroviral treatment (ART), for a median duration of 9 years, 74% were on a protease inhibitor-based regimen. Twenty-nine patients were followed-up at the end of 2015. Twenty-three were transferred to the Infectious Disease Clinic and the median age for transition was 19 years. At the end of 2015, 90% were treated with ART and 61% had an integrase inhibitor-based treatment. Of those treated with ART for more than 6 months, 90% (2013) and 96% (2015) had a viral load < 50 HIV RNA copies/mL, despite resistance problems and complicating social factors. These figures were higher than reported in other studies and similar to the treatment results in the adult HIV population in Sweden. CONCLUSIONS: The present study showed that it is possible to achieve good treatment results in adolescents with HIV.

Internal herniation after laparoscopic antecolic Roux-en-Y gastric bypass: a nationwide Danish study based on the Danish National Patient Register.

BACKGROUND: Laparoscopic Roux-en-Y gastric bypass (LRYGB) is the most common surgical treatment for morbid obesity in Denmark. Internal herniation (IH) or intermittent internal herniation (IIH) is a major late complication after LRYGB due to persistent mesenteric defects. However, the incidence of IH/IIH is still not known in Denmark. OBJECTIVES: The primary aim of the study was to assess the incidence of IH/IIH after LRYGB performed in the period between 2006 and 2011 with a follow-up until 2013, where mesenteric defects were not routinely closed during the primary operation. SETTING: Department of Bariatric Surgery, Koege University Hospital, Denmark METHODS: We performed a retrospective nationwide analysis of prospectively collected data from all patients with LRYGB performed in Denmark from 2006 to 2011 based on the Danish National Patient Registry (NPR). From January 2006 to December 2011, 12,221 patients underwent an LRYGB procedure in Denmark. Relevant data from all 12,221 patients were retrieved from the NPR during the follow-up period from January 2006 to May 2013; we registered possible subsequent abdominal operations in these patients. RESULTS: Operations were performed on 398 patients because of suspected IH/IIH; 383 of these patients had IH/IIH (3.1%; 95% CI 2.8-3.5). The estimate for the 5-year cumulative incidence of clinically significant cases with IH/IIH was 4%. The median time interval until the onset of IH/IIH after LRYGB was 15 months (range 0-67 months) in a follow-up period with a median of 38 months (range 16-87 months). CONCLUSION: In the period from 2006 to 2011, mesenteric defects were not routinely closed during LRYGB in Denmark. The cumulative 5-year incidence of IH/IIH after LRYGB was 4% in a median follow-up period of 38 months (range 16-87) in Denmark when data was retrieved from the NPR.

Six-week follow-up after HIV-1 exposure: a position statement from the Public Health Agency of Sweden and the Swedish Reference Group for Antiviral Therapy.

In 2014 the Public Health Agency of Sweden and the Swedish Reference Group for Antiviral Therapy (RAV) conducted a review and analysis of the state of knowledge on the duration of follow-up after exposure to human immunodeficiency virus (HIV). Up until then a follow-up of 12 weeks after exposure had been recommended, but improved tests and new information on early diagnosis motivated a re-evaluation of the national recommendations by experts representing infectious diseases and microbiology, county medical officers, the RAV, the Public Health Agency, and other national authorities. Based on the current state of knowledge the Public Health Agency of Sweden and the RAV recommend, starting in April 2015, a follow-up period of 6 weeks after possible HIV-1 exposure, if HIV testing is performed using laboratory-based combination tests detecting both HIV antibody and antigen. If point-of-care rapid HIV tests are used, a follow-up period of 8 weeks is recommended, because currently available rapid tests have insufficient sensitivity for detection of HIV-1 antigen. A follow-up period of 12 weeks is recommended after a possible exposure for HIV-2, since presently used assays do not include HIV-2 antigens and only limited information is available on the development of HIV antibodies during early HIV-2 infection. If pre- or post-exposure prophylaxis is administered, the follow-up period is recommended to begin after completion of prophylaxis. Even if infection cannot be reliably excluded before the end of the recommended follow-up period, HIV testing should be performed at first contact for persons who seek such testing.

Does the closure of mesenteric defects during laparoscopic gastric bypass surgery cause complications?

BACKGROUND: A well-known complication of laparoscopic Roux-en-Y gastric bypass surgery (LRYGB) is bowel obstruction due to internal herniation (IH). Evidence suggests that mesenteric defects should be closed during LRYGB to reduce the risk of IH. Therefore, surgeons are now closing mesenteric defects during LRYGB using sutures, clips, or fibrin glue. However, it has been reported that complications may arise due to the closure of mesenteric defects. The aim of this review was to summarize the reported possible complications associated with the closure of mesenteric defects during LRYGB. METHODS: A literature search of PubMed and EMBASE was performed to identify studies related to the closure of mesenteric defects during LRYGB. The studies were screened for the listing of possible complications associated with the closure of mesenteric defects. This systematic review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis recommendations. RESULTS: Thirty studies complied with the inclusion criteria for our analysis, which included 21,789 patients. Reported complications related to closure of the mesenteric defects were: small bowel obstruction because of IH, kinking, and adhesions. IH occurred because of incomplete closure of the mesenteric defects in 1.4% of all patients, 1.2% by the antecolic approach, and 1.9% by the retrocolic approach, respectively. Kinking of the small bowel occurred in .2% of 1630 patients after closure of the mesenteric defects with clips and adhesion formation was found among 4.6% of 152 patients after closure of the mesenteric defects with nonabsorbable sutures. CONCLUSIONS: The reported risk of complications caused by closure of the mesenteric defects during LRYGB seems low.

Changes in Hematology and Calcium Metabolism After Gastric Bypass Surgery--a 2-Year Follow-Up Study.

BACKGROUND: Concerns regarding nutritional deficiencies have recently emerged after Roux-en-Y gastric bypass (RYGB). METHODS: A total of 835 subjects underwent RYGB, age 43.3 years, body mass index (BMI) 47.2 kg/m(2). Hematological and calcium metabolic variables were measured before, 6, 12, and 24 months after surgery. Daily supplement of 800 mg calcium, 800 U vitamin D, a multivitamin, and a vitamin B12 injection (1 mg) every third month was recommended. In subjects with low ferritin and decreasing hemoglobin levels, oral, or intravenous iron was administered. RESULTS: Hemoglobin concentration decreased from before surgery to month 24 for both men (9.3 ± 0.05 vs. 8.3 ± 0.08 mmol/L, p < 0.001) and women (8.4 ± 0.03 vs. 7.7 ± 0.06 mmol/L, p < 0.001). At 24 months, anemia was present in 25.8 % of women and 22.1 % of men. Predictors of anemia in both sexes were baseline hemoglobin (p < 0.001), excessive weight loss in men, and younger age in women (p < 0.001). Plasma ferritin levels decreased in both sexes (p < 0.01), whereas concentrations of folic acid and vitamin B12 increased from before surgery to 24 months after surgery (p < 0.001). Vitamin D increased from baseline to month 24 in both sexes (p < 0.01). In women, PTH increased from baseline to month 24 (p < 0.05) with no changes in calcium or magnesium. CONCLUSIONS: Supplementation of calcium and vitamin D was sufficient. Iron substitution did not prevent anemia, which especially affected premenopausal women. More attention should be given to iron substitution after RYGB.

Effect of closure of the mesenteric defect during laparoscopic gastric bypass and prevention of internal hernia.

INTRODUCTION: The aim of this study is to evaluate the benefits and disadvantages of closing the mesenteric defects during gastric bypass to avoid internal herniation (IH). MATERIAL AND METHODS: The study is performed as a single-centre, randomised, controlled, blinded trial. Patients are randomly assigned to either conventional laparoscopic Roux-en-Y gastric bypass (LRYGB) without closing the mesenteric defects (n = 250) or RYGB with closing of the defects with hernia clips (n = 250). Follow-up is conducted at six months, one year, two years and five years after RYGB. The primary endpoint is the incidence of IH. CONCLUSION: This study will be the first Danish, randomised, controlled study comparing conventional LRYGB with and without closure of the mesenteric defects. The results will contribute to evidence-based recommendations for the prevention of IH. FUNDING: not relevant. TRIAL REGISTRATION: The study was registered with the Danish Data Protection Agency (SN-10-2012) and The Central Denmark Regional Committees on Biomedical Research Ethics (1-01-83-0209-12, SJ-284). The study is registered with clinicaltrials.gov: NCT01595230.

Carotid intima-media thickness is reduced 12 months after gastric bypass surgery in obese patients with type 2 diabetes or impaired glucose tolerance.

AIM: To investigate whether Roux-en-Y gastric bypass surgery (RYGB) - an in vivo model for normalisation of hyperglycaemia - improves carotid intima-media thickness (IMT) in patients with type 2 diabetes (T2D)/impaired glucose tolerance (IGT) and normal glucose tolerance (NGT). METHODS: Observational prospective study, 34 obese patients (T2D (n = 14)/IGT (n = 4), and NGT (n = 16)) were investigated before and six and 12months after RYGB. RESULTS: Mean carotid IMT was significantly reduced 12months after RYGB in patients with T2D/IGT (-0.041 mm (95% CI -0.069; -0.012, p = 0.005)) but not in patients with NGT (-0.010 mm (-0.039; 0.020, p = 0.52)). The between-group difference was not significant (p=0.13). Twelve months after RYGB, patients with respectively T2D/IGT and NGT demonstrated changes in weight: -29.9 kg, p<0.001/-30.6 kg, p < 0.001, HbA1c: -0.7%, p < 0.001/-0.1%, p = 0.33, systolic blood pressure: -2 mmHg, p = 0.68/-10 mmHg, p = 0.01 and diastolic blood pressure: -8 mmHg, p = 0.003/-11 mmHg, p < 0.001. 80% of T2D patients terminated antihyperglycaemic medication. CONCLUSION: Mean carotid IMT was significantly reduced 12months after RYGB in patients with T2D/IGT which provides evidence to support that the earliest atherosclerotic changes in the arterial wall are reversible. Although numerically different from the changes observed in patients with NGT, the between-group difference was not statistically significant.

Early enhancements of hepatic and later of peripheral insulin sensitivity combined with increased postprandial insulin secretion contribute to improved glycemic control after Roux-en-Y gastric bypass.

Roux-en-Y gastric bypass (RYGB) improves glycemic control within days after surgery, and changes in insulin sensitivity and ß-cell function are likely to be involved. We studied 10 obese patients with type 2 diabetes (T2D) and 10 obese glucose-tolerant subjects before and 1 week, 3 months, and 1 year after RYGB. Participants were included after a preoperative diet-induced total weight loss of -9.2 ± 1.2%. Hepatic and peripheral insulin sensitivity were assessed using the hyperinsulinemic- euglycemic clamp combined with the glucose tracer technique, and ß-cell function was evaluated in response to an intravenous glucose-glucagon challenge as well as an oral glucose load. Within 1 week, RYGB reduced basal glucose production, improved basal hepatic insulin sensitivity, and increased insulin clearance, highlighting the liver as an important organ responsible for early effects on glucose metabolism after surgery. Insulin-mediated glucose disposal and suppression of fatty acids did not improve immediately after surgery but increased at 3 months and 1 year; this increase likely was related to the reduction in body weight. Insulin secretion increased after RYGB only in patients with T2D and only in response to oral glucose, underscoring the importance of the changed gut anatomy.

Reduction in cardiovascular risk factors and insulin dose, but no beta-cell regeneration 1 year after Roux-en-Y gastric bypass in an obese patient with type 1 diabetes: a case report.

Experience with Roux-en-Y gastric bypass in patients with type 1 diabetes is very limited, despite an increasing prevalence of obesity also in this population. We describe changes in anthropometric measures, insulin dose, HbA1c, blood pressure, lipid status, and metabolic response to a liquid mixed meal throughout the first year after RYGB in an obese patient with type 1 diabetes. No change in HbA1c was observed, but a 48% reduction in weight-adjusted insulin dose and improvements in cardiovascular risk factors was seen 1 year after surgery. Exaggerated secretions of anorexigenic gut hormones were seen during the meals.